Trial Review

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Impact of intravenous oxytocin on lung haemodynamics and gas exchange during caesarean section under general and spinal anaesthesia

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Scientific title

Impact of intravenous oxytocin on lung haemodynamics and gas exchange during caesarean section under general and spinal anaesthesia

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Secondary ID [1]2872460

None

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Universal Trial Number (UTN)

U1111-1173-0232

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Trial acronym

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

oxygen saturation during caesarean section under general and spinal anaesthesia2958610

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Condition category

Condition code

Anaesthesiology29611129611100

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Anaesthetics

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Reproductive Health and Childbirth29767629767600

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Childbirth and postnatal care

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Intervention/exposure

Study type

Observational

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Patient registry

False

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Target follow-up duration

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Target follow-up type

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Description of intervention(s) / exposure

Study involves patients scheduled for elective caesarean section under spinal (group 1) and general anaesthesia (group 2). All of the patients will be managed by the standard, routine spinal and general anaesthesia methods and will be monitored by the standard methods (pulse oximetry, ECG electrodes, non-invasive blood pressure). After clamping and cutting of the umbilical cord, 10 I.U. of synthetic oxytocin (the dose of oxytocin requested by the obstetrician due to the low uterine tone intraoperatively) will be given intravenously as a bolus and 10 I.U. of oxytocin will be given as an infusion through 3 minutes in all of the patients. Any changes in oxygen saturation after intravenous application of oxytocin, as well as the changes in pulse and mean arterial pressure (MAP) will be recorded.

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Intervention code [1]2925380

Not applicable

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Comparator / control treatment

Concerning the reduction of the bleeding of the uterus during caesarean section by administering oxytocin intravenously, both groups of patients (those undergoing elective caesarean section under spinal anaesthesia (group 1) and those undergoing elective caesarean section under general anaesthesia (group 2)) are treated the same: 10 I.U. of oxytocin intravenously as a bolus and 10 I.U. of oxytocin in infusion. Oxygen saturation, MAP and pulse are being compared between the two groups. Each group of patients implies standard treatment because both spinal and general anaesthesia are considered as legitimate and standard methods of providing anaesthesia for caesarean section, as well as the doses of oxytocin given to both groups. The two groups are mutually compared as the goal of the study is to quantify the potential impact of oxytocin on lung haemodynamics and consequently on oxygen saturation in both groups, as well as the possible difference in oxygen saturation between the two groups.

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Control group

Active

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Outcomes

Primary outcome [1]2957860

changes in oxygen saturation after apllication of intravenous oxytocin by pulse oximetry

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Timepoint [1]2957860

Period after intravenous application of oxytocin until the end of the surgical procedure (caesarean section)

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Secondary outcome [1]3165190

changes in mean arterial pressure (MAP) by non-invasive blood presurre and pulse by pulse oximetry after intravenous application of oxytocin

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Timepoint [1]3165190

period after intravenous application of oxytocin until the end of the surgical procedure (caesarean section)

Statistical analysis will be performed using MedCalc Software version 12.1.3. (Mariakerke, Belgium). X2 test will be used to compare categorical variables. Numerical variables will be tested for the normality of distribution using Kolmogorov-Smirnov test and presented as mean +/- standard deviation or median (interquartile range) as appropriate. t test will be used to compare normally distributed variables, while nonparametric Mann-Whitney U-test to compare data that will not meet normal distribution. A P value <0.05 will be considered as significant. The sample size was calculated due to difference of means and standard deviations with alpha 0.05 (type I error) and beta 0.20 (type II error). For the study to have 90% power at P<0.05, a sample of 35 patients per group was required.

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Recruitment

Recruitment status

Completed

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Date of first participant enrolment

Anticipated

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Actual

3/08/2015

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Date of last participant enrolment

Anticipated

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Actual

30/12/2015

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

70

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Accrual to date

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Final

70

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Recruitment outside Australia

Country [1]71090

Croatia

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State/province [1]71090

Zagreb

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Funding & Sponsors

Funding source category [1]2918820

Hospital

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Name [1]2918820

Obstetrics and Gynecology Clinic, Clinical Hospital Center Zagreb

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Address [1]2918820

Petrova 13, 10000 Zagreb, Croatia, European Union

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Country [1]2918820

Croatia

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Primary sponsor type

Hospital

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Name

Obstetrics and Gynecology Clinic, Clinical Hospital Center Zagreb

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Address

Petrova 13, 10000 Zagreb, Croatia, European Union

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Country

Croatia

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Secondary sponsor category [1]2905480

None

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Name [1]2905480

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Address [1]2905480

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Country [1]2905480

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]2933950

Ethical Committe of the Obstetrics and Gynecology Clinic

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Ethics committee address [1]2933950

Petrova 1310000 Zagreb

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Ethics committee country [1]2933950

Croatia

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Date submitted for ethics approval [1]2933950

01/04/2015

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Approval date [1]2933950

23/04/2015

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Ethics approval number [1]2933950

021-1/54-2015

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Summary

Brief summary

Intravenous application of synthetic oxytocin after caesarean section delivery and umbilical cord transection is a common and widely accepted method for reducing postpartal bleeding and prevention of uterine atony. There are numerous clinical studies which have proven that after intravenous oxytocin application, due to the vasodilation effect, reducement in peripheral resistence occurs and mean arterial pressure (MAP) decreases. In response to those changes, compensatory tachycardia occurs and stroke volume of the heart increases. Although the impact of oxytocin on systemic circulation is known for decades, there is not much knowledge about the impact of oxytocin on lung haemodynamic and gas exchange. Due to our clinical observations, we decided to examine the impact of oxytocin on arterial oxygen saturation in caesarean section patients and to determine the possible difference in arterial oxygen saturation between general and spinal anaesthesia after intravenous application of oxytocin.